In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called ...
Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...
In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...
Brian Coggio, Karrie Wheatley Ph.D. Courts may infer the requisite specific intent from statements that appear in the generic manufacturer’s label. “When proof of intent depends on the label ...
Despite increased labeling of drugs with pediatric information, most medicines remain available only as pills meant for ...
Please provide your email address to receive an email when new articles are posted on . Although immune-based therapies have penetrated many medical specialties, including rheumatology, some experts ...
The FDA added the postmarketing reports of ileus, or blocked intestines, to the drug labeling for semaglutide (Ozempic). "Because these reactions are reported voluntarily from a population of ...
FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
Peter Botten, President and CEO, Codonics Inc. Codonics Inc. is combating drug labeling errors in the medical field with the Safe Label System. This technology increases syringe labeling compliance ...
FDA updates label on controversial Alzheimer's drug, saying it's only meant for early-stage patients
A month after approving a controversial new Alzheimer's drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use. The Food and Drug ...
A U.S. appeals court panel signaled that it wants to ensure generic-drug makers can continue selling low-cost copycat medicines with limited-use labels as long as they don’t actively promote newer ...
California could become the first state to make its own prescription drugs under a proposal announced Thursday by Governor Gavin Newsom. The effort could "take the power out of the hands of greedy ...
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